Sound bites from HR? Intarcia is full of DBs like you and perfect place since y'all will be fired when your dream goes up in flame.
Only a month to go till Teva's GENERIC GLP-1 is launched!
Intarcia Therapeutics
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Sound bites from HR? Intarcia is full of DBs like you and perfect place since y'all will be fired when your dream goes up in flame.
Only a month to go till Teva's GENERIC GLP-1 is launched!
He was once hailed as the king of biotechnology. In the industry’s frontier days, David Blech was the top gunslinger, quick to draw his checkbook to start new companies or prop up faltering ones.
Mr. Blech was the initial financial force behind the industry giant Celgene, the rare disease specialist Alexion Pharmaceuticals, and the cancer drug developer Ariad Pharmaceuticals, not to mention Icos, which developed the impotence pill Cialis.
In the early 1990s, Mr. Blech was worth about $300 million and made the Forbes list of 400 wealthiest Americans.
Now, however, he is about to begin a four-year prison term, about $11 million in debt and mainly an afterthought to the industry he helped foster.
Mr. Blech was the initial financial force behind the industry giant Celgene, the rare disease specialist Alexion Pharmaceuticals, and the cancer drug developer Ariad Pharmaceuticals, not to mention Icos, which developed the impotence pill Cialis.
In the early 1990s, Mr. Blech was worth about $300 million and made the Forbes list of 400 wealthiest Americans.
Now, however, he is about to begin a four-year prison term, about $11 million in debt and mainly an afterthought to the industry he helped foster.
Thanks for the newsflash - from 2013.
Today was a bad day. Impurities in the batches have exceeded specifications in two lots. Data has to be discarded and new manufacturing process has to be validated. Havent heard how many patients are effected by today was our deadline for submission of data to show that the two lots could be used. When I left big huddle going on about what to do.
No worries. Issue with that badly "designed" joke spray drier again? Its like whack the mole of either the impurities or micro contaminations at Hayweird.
Let TA who ultimately created all this mess step up in a way and resign before he gets FIRED. Or TH and new Quality VP GK fix it as its about time those boys do something but nevermind as they are both bullshitters. LOL
World's greatest leader dinged by FDA ? Impossible why no one stands taller or talks more impressively than the King of Greatness - KG. Hilarious to see this stupid monkey lie his way out of this one
Dying unicorn alert!
http://www.biopharmadive.com/news/intarcia-fda-rejection-crl-diabetes-device-combo/506030/
Intarcia loses some of its sparkle with FDA rejection
Published
Sept. 28, 2017
Dive Brief:
Dive Insight:
Dubbed a biotech "unicorn" due to its lofty valuation, Intarcia has a strong cash position, raising over $600 million through September in a private equity financing. The well-funded company has said publicly it is unlikely to seek an initial public offering prior to commercialization of its lead product for fear of leaving value on the table. Past investments have put the company's value as high as $5 billion.
The company has been developing a drug-device combo that uses a decades-old diabetes drug in an implant. The device is inserted under the skin through a non-invasive procedure, providing diabetics with months of consistent drug therapy.
"Real-world outcomes data consistently demonstrate that the majority of patients living with type 2 diabetes struggle to adhere to chronic pills and injections," said Intarcia Chairman, CEO and President Kurt Graves in a statement. "Diabetes remains a devastating public health crisis that is still spiraling out of control because of poor control and poor adherence issues."
ITCA 650 uses the drug exenatide, which is a GLP-1 agonist first approved as Byetta in 2005. A long-acting weekly version of the drug was later approved under the name Bydureon.
While Byetta was a first-in-class drug, the GLP-1 class has expanded rapidly and is now widely used as an add-on to insulin in patients with type 2 diabetes. Some of these drugs have even shown the ability to reduce the risk of cardiovascular death in large cardiovascular outcomes trials.
Intarcia is banking on physicians being comfortable with the use of ITCA 650 because of their long relationship with Byetta and Bydureon.
The company hopes that, by providing a more consistent means of administration for the drug, they can improve patient compliance (and outcomes), while bringing in blockbuster sales.
Complete response letters are not publicly disclosed by the FDA, meaning it is up to the company to reveal what such a rejection might entail — there is no way to check how transparent companies are about a letter's contents.
Intarcia’s statement indicates the company intends to resolve the issue quickly. Yet, the company did not give any timeline around when it plans to refile.
http://www.biopharmadive.com/news/intarcia-fda-rejection-crl-diabetes-device-combo/506030/
Intarcia loses some of its sparkle with FDA rejection
Published
Sept. 28, 2017
Dive Brief:
- Intarcia Therapeutics, Inc. revealed Wednesday the Food and Drug Administration has rejected its type 2 diabetes drug-device combo ITCA 650, sending the Boston-based company a complete response letter (CRL).
- The privately-held biotech said it does not expect to have to conduct any further clinical trials or any "long-lead time chemistry, manufacturing and controls activities" to fulfill the requirements laid out in the agency's rejection letter.
- Intarcia said it has clear and constructive advice to deal with the manufacturing issues in the CRL, but gave no further details.
Dive Insight:
Dubbed a biotech "unicorn" due to its lofty valuation, Intarcia has a strong cash position, raising over $600 million through September in a private equity financing. The well-funded company has said publicly it is unlikely to seek an initial public offering prior to commercialization of its lead product for fear of leaving value on the table. Past investments have put the company's value as high as $5 billion.
The company has been developing a drug-device combo that uses a decades-old diabetes drug in an implant. The device is inserted under the skin through a non-invasive procedure, providing diabetics with months of consistent drug therapy.
"Real-world outcomes data consistently demonstrate that the majority of patients living with type 2 diabetes struggle to adhere to chronic pills and injections," said Intarcia Chairman, CEO and President Kurt Graves in a statement. "Diabetes remains a devastating public health crisis that is still spiraling out of control because of poor control and poor adherence issues."
ITCA 650 uses the drug exenatide, which is a GLP-1 agonist first approved as Byetta in 2005. A long-acting weekly version of the drug was later approved under the name Bydureon.
While Byetta was a first-in-class drug, the GLP-1 class has expanded rapidly and is now widely used as an add-on to insulin in patients with type 2 diabetes. Some of these drugs have even shown the ability to reduce the risk of cardiovascular death in large cardiovascular outcomes trials.
Intarcia is banking on physicians being comfortable with the use of ITCA 650 because of their long relationship with Byetta and Bydureon.
The company hopes that, by providing a more consistent means of administration for the drug, they can improve patient compliance (and outcomes), while bringing in blockbuster sales.
Complete response letters are not publicly disclosed by the FDA, meaning it is up to the company to reveal what such a rejection might entail — there is no way to check how transparent companies are about a letter's contents.
Intarcia’s statement indicates the company intends to resolve the issue quickly. Yet, the company did not give any timeline around when it plans to refile.
Hot off the press! CRL CRL CRL 
As mentioned here many times - Intarcia gets the scarlet letter AKA Complete Response Letter from FDA!
Dead unicorns and for those FTEs and army of consultants - layoffs.
Told ya!
As mentioned here many times - Intarcia gets the scarlet letter AKA Complete Response Letter from FDA!
Dead unicorns and for those FTEs and army of consultants - layoffs.
Told ya!
Of all the arrogant, rude, obnoxious, self obsessed, delusions of grandeur companies on planet earth - Intarcia is Number 1 for over promotion, lying, scum sucking, turd eating, evil behavior. May Hell Embrace Their Demise.
This is the funniest thing that could possibly happen. Did anyone get to see the Midget dance and jump up and down ??
Now stay tuned for "The Hunt For the Guilty" - the Midget must execute all who are at fault. Since the Midget is to be worshiped all mistakes are made by the minions. Execute them, Execute them !!!
Ha Ha Ha what a f'ng joke the Midget and his Mormon Boyfriend
This is the funniest thing that could possibly happen. Did anyone get to see the Midget dance and jump up and down ??
Now stay tuned for "The Hunt For the Guilty" - the Midget must execute all who are at fault. Since the Midget is to be worshiped all mistakes are made by the minions. Execute them, Execute them !!!
Ha Ha Ha what a f'ng joke the Midget and his Mormon Boyfriend
When the FDA walked into the room we shouted "THIS IS THERANOS" then we pushed them into a well
Get this the fxckn idiot executive director of Quality, a well known ahole and very disliked buffoon got promoted to VP of Global Quality 2 months ago. His Indian mommy the VP of Regulatory protected his sorry ass. This ahole left Dodge to hide in India to take care of family or something. It was 2nd time this chump pulled this off. Atta boy Gopi. See you in the unemployment line!
Please don't insult Bevis' Cornholio!
I am the Great Cornholio, Why do I not use T.P for my Pee Pee
https://www.youtube.com/watch?v=Hbw8UMcqUJ4
Graves has been digging his own GRAVE. Guess he won't be checking them milestone checks from bagholder investors and especially very pissed off Servier!
From local paper:
FDA balks at Intarcia’s diabetes drug pump
- September 28, 2017
Intarcia, which last year was valued at about $3.5 billion, brought in $600 million in its latest funding round.
WHOA! Intarcia investing/speculating in real estate in Vietnam with Korean VC? WTF?
http://www.newsworld.co.kr/detail.htm?no=3451
Shinhan I&F Eyes to take over Stake in Nova Land Group in Vietnam jointly with Intarcia Therapeutics
The move first by South Korean securities firm to take over directly stake in foreign firm overseas and Intarcia, a U.S. pharmaceutical firm engaged in development of medication for diabetes soon to list its shares in New York Exchange
26(Tue), Sep, 2017
Shinhan Financial Investment, the control tower for Shinhan Financial Group’s investment banking sector, is in the middle of taking a stake in Nova Land Group, a real estate development company in Vietnam, jointly with Intarcia Therapeutics, a U.S. bio-technology company. The price tag is set at for 230 billion won. The move is considered a rare opportunity as it concerns a securities firm taking a stake in a foreign real estate firm directly without involving an agent.
According to investment banking sources on Aug. 24, the Korean securities firm set up a consortium with Tyrus Holdings’ Starset Investment and has been at work to take over a stake of 1.66 million preferred shares or a 1.84 percent, in Intarcia Therapeutics Inc., worth $100 million. Now a fund is being put together publicly in the name of Shinhan Global Healthcare Investment Cooperative No. 2.
Intarcia has been working mainly researching cures for diabetes. It developed an under-skin injection-type pump to inject medication for diabetes patients. The company applied to the FDA for a license to use it commercially last November. If approved, it is expected to boost the market value of the company from the current 4 trillion won. The expectation is so high that a number of well-known investors, including hedge funds and asset management firms, chose to investment in the firm, including the Bill and Melinda Foundation, Fidelity Global Investment, Morgan Stanley and Baupost. Intarcia is scheduled to be listed on the New York Stock Exchange in 2019.
Intarcia is scheduled to be listed on the New York Stock Exchange in 2019.
Ha Ha Ha Ha broke ass donkey dont get listed
Ha Ha Ha Ha broke ass donkey dont get listed
Most of this is a cover up, people have know about the contaminants for years especially impurities. Please send the proof to NY Times or post more of it here
I.R.S. Awards $104 Million to Bradley Birkenfeld, a Whistle-Blower ...
www.nytimes.com/2012/09/12/.../whistle-blower-awarded-104-million-by-irs.html?...
Sep 11, 2012 - But Mr. Birkenfeld, 47, has a lot to show for his time and effort: The Internal Revenue Service acknowledged on Tuesday that information he had provided was so helpful that he would receive a $104 million whistle-blower award for revealing the secrets of the Swiss banking system.
Pharma Fraud Lawyers Help You Earn Whistleblower Cash Awards
https://www.mahanyertl.com/pharmaceutical-fraud-whistleblowers/
False Claims Act Lawyers & Pharmaceutical Fraud Whistleblowers - $17 Billion RecentWhistleblower Wins: Drug Co Kickbacks, Off Label Mktg ...
Whistleblower gets cut of $38 million pharma case
www.jsonline.com/story/news/blogs/proof.../whistleblower...pharma.../95620270/
Dec 20, 2016 - A drug company has agreed to pay $38 million to settle a federal fraud case launched by a whistleblowing sales representative from ...
7 Biggest Whistleblower Rewards - ABC News
abcnews.go.com/Business/biggest-whistleblower-rewards/story?id=17222028
Sep 17, 2012 - Here are some top recent whistleblower awards: 1. ... awarded $102 million for having exposed the illegal promotion of the arthritis drug Bextra, ...
Every patient given a contaminated drug put their lives at risk - speak up- the person you save could be someone you care about
I.R.S. Awards $104 Million to Bradley Birkenfeld, a Whistle-Blower ...
www.nytimes.com/2012/09/12/.../whistle-blower-awarded-104-million-by-irs.html?...
Sep 11, 2012 - But Mr. Birkenfeld, 47, has a lot to show for his time and effort: The Internal Revenue Service acknowledged on Tuesday that information he had provided was so helpful that he would receive a $104 million whistle-blower award for revealing the secrets of the Swiss banking system.
Pharma Fraud Lawyers Help You Earn Whistleblower Cash Awards
https://www.mahanyertl.com/pharmaceutical-fraud-whistleblowers/
False Claims Act Lawyers & Pharmaceutical Fraud Whistleblowers - $17 Billion RecentWhistleblower Wins: Drug Co Kickbacks, Off Label Mktg ...
Whistleblower gets cut of $38 million pharma case
www.jsonline.com/story/news/blogs/proof.../whistleblower...pharma.../95620270/
Dec 20, 2016 - A drug company has agreed to pay $38 million to settle a federal fraud case launched by a whistleblowing sales representative from ...
7 Biggest Whistleblower Rewards - ABC News
abcnews.go.com/Business/biggest-whistleblower-rewards/story?id=17222028
Sep 17, 2012 - Here are some top recent whistleblower awards: 1. ... awarded $102 million for having exposed the illegal promotion of the arthritis drug Bextra, ...
Every patient given a contaminated drug put their lives at risk - speak up- the person you save could be someone you care about
Interesting tidbits from Hayward insider:
CRL due to the deplorable pump manufacturing. Sounds like FDA caught on with the impurities and contamination issues which demand whole NEW manufacturing process!
KG demands fix in 6 months but SMEs say at least18 months just in time for the key patent expirations.
They produced tons of inventory for the launch which all need to be shit-canned. It can't get better than this!
CRL due to the deplorable pump manufacturing. Sounds like FDA caught on with the impurities and contamination issues which demand whole NEW manufacturing process!
KG demands fix in 6 months but SMEs say at least18 months just in time for the key patent expirations.
They produced tons of inventory for the launch which all need to be shit-canned. It can't get better than this!